Since this almost certainly sounds the death-knell for the present effort to outlaw by legislation patent claims directed to isolated genes, and other biological materials, there are no doubt many in the genetics, biotechnology, biologics and pharmaceuticals industries – to name but a few of the contributors of opposing submissions to the Committee – breathing a sigh of relief that this episode is over.

However, as we reported previously, one reason for the delay in reporting was rumoured to be an irreconcilable split in the views of the Committee. In fact, the final report includes – in addition to the 60-odd pages of the majority report – a further 50 pages or so comprising a detailed dissenting report by Senators Heffernan, Xenophon and Siewert. This comes as no surprise to Patentology, since we previously predicted that these three Committee members were most likely immovable in their desire to recommend that the Bill be adopted by the Senate. They were the backers of the Bill in the first place, were clearly hostile (in varying degrees) to opponents of the Bill who appeared at the public hearings, and quite plainly were never going to be persuaded to any alternative point-of-view.

Equally unsurprising, therefore, is the dissenting recommendation that the Senate should pass the Bill, with the amendments put forward by Senator Heffernan at the public hearings (details of which may be found in the post Update on the Australian Senate Gene Patent Inquiry).

CONTENT OF THE COMMITTEE ‘MAJORITY REPORT’

By far the largest part of the majority report (nearly 40 pages) is devoted to a review of the various submissions received by the Committee. This is entirely appropriate, considering the very large number of submissions, and the considerable effort that clearly went into their preparation.

The Committee identified no fewer than 13 ‘key issues’ raised by the submissions, summarised as follows:

the drafting of the Bill, in particular its potential ambiguity, possible unintended consequences, and failure to align with its title and stated purpose;

the efficacy of the Bill, in particular questions of whether it would actually achieve its stated intent;

the need for the Bill, and in particular the question of whether or not the problems that the Bill is ostensibly intended to solve actually exist;

the nature of discovery and invention, and in particular whether or not there are in fact clear definitions of, and distinctions between, ‘discoveries’ and ‘inventions’ within the existing patent law that might be reinforced by the proposed amendments;

the impact of the Bill on healthcare;

the impact of the Bill on investment;

the impact of the Bill on research and development;

the impact of the Bill on access to products;

the impact of the Bill on access to knowledge;

ethical issues related to the Bill, and in particular whether the moral and ethical concerns raised by some submissions are based upon a sound understanding of the relevant principles of patent law, and whether the Bill would, in any event, actually serve to address these concerns;

Australia's international obligations, particularly whether the Bill is consistent with obligations under existing treaties to which Australia is a party, as well as the general potential benefits of international harmonisation;

support for other policy approaches, including those proposed by a number of reports and inquiries into patent law reform in recent years.

Out of the various submissions on these topics, the Committee identified the following issues to be, in its view, the most significant:

the distinction between discoveries and inventions;

the scope of the Bill's exclusion for biological materials;

access to treatments, diagnostics and methods for healthcare;

the freedom to conduct research;

investment in research and development;

access to new products and knowledge;

ethical issues with respect to the patenting of human genes and biological materials;

the crown use and compulsory licensing provisions of the Patents Act; and

international considerations.

In reaching a recommendation, and after reviewing these issues, the Committee concluded that while the Bill was ‘well-intentioned’, it did not agree that:

… the Bill represents an effective solution to the problems which may be caused by patents over human genes and biological materials. In particular, the committee is concerned that proposed amendments in the Bill, which are focused on addressing a specific issue, could have a large number of unintended consequences across the entire patent system with indeterminate impacts on a range of industries and sectors.

Like many of those who gave evidence, the committee prefers the solutions offered in the proposed amendments of the Raising the Bar Bill. However, the committee does not consider that the amendments in the Raising the Bar Bill will resolve all of the issues in the patent system. In the opinion of the committee, serious consideration should also be given to the proposals for legislative enactment of the patentable subject matter test and the general 'ethical' exclusion made in the ACIP report on patentable subject matter. Other reforms may also be necessary in the future…. Despite the need for further reform to the patent system, the committee agrees that removing an area of patentable subject matter, as proposed by the Bill, is not an appropriate solution to this complex set of issues.

THE DISSENT

In sharp contrast to the majority’s report, the Dissenting Report devotes little more than three pages to express discussion of the submissions made to the Inquiry, and this is focussed almost entirely – and without balance – upon those submissions made in support of the Bill.

This imbalance is justified by characterising the opposing submissions as coming

…mainly from sectorial interests associated with the biotechnology, pharmaceutical and agri-biotech industry. Along with Ausbiotech, the peak biotech industry association in Australia, the critics include patent attorneys, patent lawyers, research scientists, patent and legal professional associations, medical and scientific research institutes and their representative professional bodies and Australian universities who are either the holders of patents which contain claims to biological materials that are identical or substantially identical to those that exist in nature or who have acted for, procured, or benefited directly or indirectly from such patents and their procurement.

The supporting submissions, on the other hand, are characterised as being

… by a more representative section of the Australian community that includes Cancer Council Australia, Department of Health and Ageing, the South Australian government, the Human Genetics Society of Australasia, the Australian Medical Association, Meat and Livestock Ltd, Cancer Voices Australia, Cancer Voices New South Wales, the Royal College of Physicians, The Royal College of Pathologists of Australasia, the Tasmanian government, Breast Cancer Action Group NSW and the Generic Medicines Industry Association.

We maintain, however, that dismissing the genuine considered arguments and submissions of knowledgeable contributors on the basis of perceived ‘self-interest’ is inappropriate, unjustified and unacceptable in a democracy.

The remainder of the Dissenting Report is principally devoted to a review of the various issues, a historical perspective, and discussion of previous inquiries and reports into the patent system, and their relative merits. Based on this content, we are inclined to conclude that the report is largely the work of Dr Luigi Palombi, the principle drafter of the Bill, and Explanatory Memorandum, rather than of the three senators whose names appear at its foot.

CONCLUSION

It is not surprising that the Committee was divided in its views and conclusions, nor is it surprising that the three senators who supported the Patent Amendment (Human Genes and Biological Materials) Bill 2010 upon its introduction continue to support its passage (albeit in amended form).

It is notable, however, that seemingly not one other member of the Committee, from either side of politics, was persuaded to join the Bill’s sponsors in dissent. This sends a strong message, which the majority of members of the Australian Senate are most likely to heed.